UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039861
Receipt number R000045461
Scientific Title The effects of food ingestion on hair
Date of disclosure of the study information 2020/03/18
Last modified on 2020/09/23 14:23:33

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The effects of food ingestion on hair

Acronym

The effects of food ingestion on hair

Scientific Title

The effects of food ingestion on hair

Scientific Title:Acronym

The effects of food ingestion on hair

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of food ingestion on hair

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hair diameter of the top of the head
Hair diameter of the side of the head

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Healthy person from 20 to 60 years of age
(2) Healthy person who eat test food amount of regulation and over or less than in a day
(3) Subjects giving written informed consent

Key exclusion criteria

(1) Individuals having symptoms that
hair-related
(2) Individuals taking supplement or medications that effect hair
(3) Individuals who have the of pregnancy

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Osawa

Organization

Lotte Co., Ltd.

Division name

Central Laboratory, Kamukoto Research Department

Zip code

336-8601

Address

1-1, Numakage-3chome, Minami-ku, Saitama

TEL

048-837-0744

Email

oosawa_kenji@lotte.co.jp


Public contact

Name of contact person

1st name Naoya
Middle name
Last name Oshima

Organization

Lotte Co., Ltd.

Division name

Central Laboratory, Kamukoto Research Department

Zip code

336-8601

Address

1-1, Numakage-3chome, Minami-ku, Saitama

TEL

048-837-0744

Homepage URL


Email

ooshima_naoya@lotte.co.jp


Sponsor or person

Institute

Lotte Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Lotte Co., Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shiba Palace Clinic

Address

6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

Tel

03-5408-1590

Email

jimukyoku@mail.souken-r.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 03 Month 12 Day

Date of IRB

2020 Year 03 Month 12 Day

Anticipated trial start date

2020 Year 03 Month 19 Day

Last follow-up date

2020 Year 07 Month 23 Day

Date of closure to data entry

2020 Year 07 Month 30 Day

Date trial data considered complete

2020 Year 07 Month 30 Day

Date analysis concluded

2020 Year 08 Month 27 Day


Other

Other related information

Study design
cohort design

Way for subscription
Everyone who exchanged the selection criteria in March-July 2020


Management information

Registered date

2020 Year 03 Month 18 Day

Last modified on

2020 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045461


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name